Greenness profile assessment to HPTLC‒UV method for the simultaneous estimation of amlodipine besylate and indapamide by NEMI, GAPI, and AGREE tools

Abstract

A wide range of analytical techniques has been reported for the determination of amlodipine besylate (AML) and indapamide (IND) in their commercialized formulations. Nevertheless, sustainable/green analytical techniques for estimating AML and IND in combination are scarce in literature. Accordingly, the present research was carried out to establish a rapid, highly sensitive, and sustainable high-performance thin-layer chromatography (HPTLC) technique for the simultaneous estimation of AML and IND using the National Environmental Method Index (NEMI), Green Analytical Procedure Index (GAPI), and analytical greenness (AGREE) tools. Metal plates coated with 250-µm silica gel 60 GF₂₅₄ were utilized for chromatographic separation. Densitometric detection was carried out at 288 nm using mobile phase ethanol‒ethyl acetate‒triethylamine (5:5:0.3, V/V). The HPTLC with ultraviolet (UV) detection method was linear in the 300‒1500 ng per band and 100‒500 ng per band ranges for AML and IND, respectively. The assay of AML and IND in the marketed formulation was found to be 101.40 ± 1.55% and 99.33 ± 1.39%, respectively, using the suggested HPTLC‒UV method. The AGREE index for the greener HPTLC‒UV technique was found to be 0.73, suggesting an excellent greenness profile for the proposed HPTLC‒UV technique. The method was validated as per the International Council for Harmonisation (ICH) Q2(R1) guidelines.